VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsib
FDA device recall Z-0866-05 · posted 2005-06-04 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days.
- Action taken
- Letters dated 4/18/2005 with instructions to process a mid-level QC fluid every eight hours when processing patient samples for valproic acid. Replacement product to be shipped as soon as available.
- Root cause
- Other
- Status
- Terminated
- Product code
- LEG
- Quantity affected
- 139 boxes
- Distribution
- 37 U.S. consignees nationwide. Ortho-Clinical foreign affiliates in England, France and Spain.
- Date initiated
- 2005-04-18
- Date posted
- 2005-06-04
- Date terminated
- 2005-10-13
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS (K042476) | Ortho-Clinical Diagnostics, Inc. | 2004-12-01 |